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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00059202 |
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Date of registration:
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21/04/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Trial of High-dose Urso in Primary Sclerosing Cholangitis
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Scientific title:
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Multicentered Randomized Trial of High-dose Urso in Primary Sclerosing Cholangitis |
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Date of first enrolment:
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April 2003 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00059202 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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- Chronic cholestatic disease of at least six months' duration.
- Serum alkaline phosphatase at least 1 ½ times the upper limits of normal.
- Retrograde, operative, percutaneous, or magnetic resonance cholangiography
demonstrating intrahepatic and/or extrahepatic biliary duct obstruction, beading, or
narrowing consistent with PSC within one year of the study entry.
- Liver biopsy in the previous one year which is available for review and compatible
with the diagnosis of PSC. Compatible biopsy features include fibrous cholangitis,
ductopenia with periportal inflammation and biliary fibrosis.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Sclerosing Cholangitis
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Intervention(s)
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Drug: Ursodeoxycholic Acid
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Primary Outcome(s)
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To complete the evaluation of the effects of urso at a dose of 28-30 mg/kg/day on time to the development of cirrhosis, varices, cholangiocarcinoma, meeting minimal listing criteria for liver transplantation, or death in patients with PSC.
[Time Frame: 5 years]
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Secondary Outcome(s)
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Compare high dose urso vs placebo on liver biochemistries, histology stage, cholangiography, Mayo Risk Score, quality of life, toxicity, tolerability, development of cholangitis. Establish a serum, tissue & data bank for future studies.
[Time Frame: 5 years]
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Secondary ID(s)
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R01DK056924
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URSO (completed)
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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